CRS FIRST DEFENDER HAND SANITIZER

CRS FIRST DEFENDER HAND SANITIZER by

Drug Labeling and Warnings

CRS FIRST DEFENDER HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by CRS Reprocessing, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CRS FIRST DEFENDER HAND SANITIZER- alcohol solution 
CRS Reprocessing, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

CRS FIRST DEFENDER HAND SANITIZER

DRUG FACTS

Active ingredient(s)

Alcohol 80% v/v

Purpose

Antiseptic

Uses(s)

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only.  Flammable. Keep away from heat or flame.

Do not use

in children less than 2 months of age

on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop using and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough product on hands to cover all surfaces, Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-31C (59-86F) 

Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP.

Topical, Non- Sterile Solution

FDA and World Health Organization Formula

Manufactured by

CRS

REPROCESSING SERVICES

569 Industrial Drive

Lewisberry, PA 17339

1-717-938-1838

www. firstdefendersanitizer.com 

Packaging

CRS FIRST DEFENDER HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78374-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78374-001-01	3.79 L in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020	09/28/2021

Labeler - CRS Reprocessing, LLC (055868923)

Revised: 1/2022

Document Id: d61d1edf-1a2b-04ca-e053-2995a90aeda4

34390-5

Set id: 2609b21e-e3f6-4868-a232-5d44aaedea88

Version: 2

Effective Time: 20220121